EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial

Sponsor
University of Campinas, Brazil
Study ID
NCT03932721
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab 140 MG/ML — DRUG
    Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C.

Study Details

Based on the current evidence, empagliflozin could reduce cardiovascular morbidity and mortality in Diabetes Mellitus Type 2 (T2DM). Anti-PCSK9 therapy (evolocumab) can reduce the major cardiovascular events incidence in secondary prevention individuals, some of them presenting T2DM. The beneficial effect of the combined use of these two agents in T2DM remains unknown. Evaluating the effect of evolocumab on top of the best of care therapy for T2DM, including empaglifozin, on endothelial function may indicate the existence of some benefit related to cardiovascular outcomes.

Key Dates

Start date
Oct 1, 2018
Status verified
Mar 2023
Primary completion
Jun 30, 2021
Completion
Oct 30, 2021

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Evolocumabe
    Patients with T2DM treated with the standard of care (SGLT2 inhibitors, maximal statin dose and ideal control of blood glucose and blood pressure) AND evolocumab (anti-PCsk9).
  • No Intervention: Control
    Patients with T2DM treated exclusive with the standard of care (SGLT2 inhibitors, maximal statin dose and ideal control of blood glucose and blood pressure).

Primary Outcome Measure

Difference in the percentage change in flow mediated dilation (FMD) [ Time Frame: 16 weeks ]

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